What is Ormeloxifene (Saheli, Centchroman)?
It belongs to the new category of agents called as Selective Estrogen Receptor Modulators (SERMs). It has a weak estrogenic and a potent antiestrogenic profile. It is expected to exert a contraceptive effect and normalize the bleeding from uterine cavity by regularizing the expression of estrogen receptors on the endometrium, it prevents proliferation of endometrium and does not affect the cornification of vaginal and cervial epithelium. Both of these processes are estrogen dependent.
Indication/Contraindication for use of Ormeloxifene (Saheli, Centchroman)
- It is best known as a non-hormonal, non-steroidal oral contraceptive which is taken once per week. It is commonly available in India as a birth control pill since the early 1990s, and it is currently marketed there under the trade name Saheli (saheli means friend in hindi).
- Contraindication to use - Jaundice or several hepatic dysfunctions, polycystic ovarian disease, chronic cervicitis or cervical hyperplasia, history of hyper sensitivity to drug, chronic illness like tuberculosis, renal disease, nursing mothers in the first 6 months of the postnatal periods.
- Dysfunctional uterine bleeding.
Side Effects of Ormeloxifene (Saheli, Centchroman)
Nausea, vomiting, headache and in some cases weight gain.
Dosage of Ormeloxifene (Saheli, Centchroman)
It is recommended that Saheli be taken twice a week for the first 16 weeks – hence the dose is 120 mg twice a week, every Sunday/Wednesday for the first 12 weeks. From the 13th week onwards, it can be taken once a week only as a 60mg dosage. Following this weekly maintenance dose of 30mg is recommended.
Precautions while prescribing Ormeloxifene (Saheli, Centchroman)
- Bi weekly and weekly dosage schedules have to be observed irrespective of menstrual periods.
- Ormeloxifene has contraceptive properties, Prolongation of menstrual cycle may be observed in some users.